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[Systematic review and Meta-analysis on efficacy and safety of Gongxuening Capsules in treatment of abnormal vaginal bleeding after medical abortion].
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica Pub Date : 2021-08-01 , DOI: 10.19540/j.cnki.cjcmm.20210201.502
Bo-Han Niu 1 , Ming-Yan Zhang 1 , Ting Zhang 1 , Hui-Zi Cai 1 , Kai Li 1 , Hui Wang 1
Affiliation  

To systematically evaluate the efficacy and safety of Gongxuening Capsules in the treatment of abnormal vaginal bleeding after medical abortion. CNKI, Wanfang, SinoMed, VIP, PubMed, Cochrane Library and EMbase databases were retrieved to comprehensively collect the clinical randomized controlled trials(RCTs) of Gongxuening Capsules for treatment of abnormal vaginal bleeding after medical abortion from the establishment of the databases to October 10, 2020. Literature screening, data extraction and quality evaluation were conducted independently by two system reviewers according to the inclusion and exclusion criteria. Cochrane Handbook bias risk assessment tool was used for the literature methodology quality evaluation, RevMan 5.3 software was used for Meta-analysis, and the evidence quality of outcomes was evaluated by the evidence quality grading system(GRADE). A total of 16 RCTs were inclu-ded. The results of Meta-analysis showed that as compared with the western medicine treatment alone, the addition of Gongxuening Capsules to the western medicine treatment can reduce the amount of vaginal bleeding(RR=1.23, 95%CI[1.19, 1.27], P<0.000 01), shorten vaginal bleeding time(RR_(≤15 d number of people)=1.39, 95%CI[1.31, 1.48], P<0.000 01; MD_(number ofdays)=-1.20, 95%CI[-1.66,-0.74],P<0.000 01). However, there was no obvious advantage in abortion effect(RR=1.02, 95%CI[0.99, 1.06], P=0.14) and menstrual recovery(MD=-0.35, 95%CI[-0.96, 0.25], P=0.25). The results of GRADE showed that the grading level was low for vaginal bleeding volume and vaginal bleeding time, and extremely low for abortion effect and mens-trual recovery. In terms of safety, 16 studies reported adverse events. Only one study showed no adverse events and the rest showed transient nausea, vomiting, stomach burning, upper abdominal discomfort and other gastrointestinal symptoms. The results show that the addition of Gongxuening Capsules to the application of western medicine in treatment of drug abortion can reduce the amount of vaginal bleeding and shorten vaginal bleeding time, but the abortion effect and menstrual recovery have no obvious advantages. The use of Gongxuening Capsules helps to achieve less adverse reactions and higher safety. Due to the small sample size of the included studies and many methodological quality problems, no conclusions with clinical guidance value can be obtained. Large sample-zise, high-qua-lity randomized controlled trials are still needed for further verification.

中文翻译:

宫血宁胶囊治疗药物流产后阴道异常出血的疗效和安全性的系统评价和Meta分析[J].

系统评价宫血宁胶囊治疗药物流产后阴道异常出血的疗效和安全性。检索CNKI、万方、SinoMed、VIP、PubMed、Cochrane Library和EMbase数据库,综合收集宫血宁胶囊自建库至10月10日治疗药物流产后阴道异常出血的临床随机对照试验(RCTs), 2020. 文献筛选、数据提取和质量评价由两名系统评价员根据纳入和排除标准独立进行。文献方法学质量评价采用Cochrane手册偏倚风险评估工具,Meta分析采用RevMan 5.3软件,结果的证据质量采用证据质量分级系统(GRADE)进行评价。共纳入 16 个 RCT。Meta分析结果显示,与单纯西药治疗相比,加用宫血宁胶囊可减少阴道出血量(RR=1.23, 95%CI[1.19, 1.27], P< 0.000 01), 缩短阴道流血时间(RR_(≤15 d人数)=1.39, 95%CI[1.31, 1.48], P<0.000 01; MD_(天数)=-1.20, 95%CI[-1.66 ,-0.74],P<0.000 01)。但在流产效果(RR=1.02, 95%CI[0.99, 1.06], P=0.14)和月经恢复(MD=-0.35, 95%CI[-0.96, 0.25], P=0.25)方面无明显优势)。GRADE结果显示阴道出血量和阴道出血时间的分级水平较低,流产效果和月经恢复极低。在安全性方面,16 项研究报告了不良事件。只有一项研究显示没有不良事件,其余研究显示一过性恶心、呕吐、胃灼热、上腹部不适和其他胃肠道症状。结果表明,加用宫血宁胶囊西药治疗药物流产可减少阴道流血量,缩短阴道流血时间,但流产效果和月经恢复无明显优势。使用宫血宁胶囊有助于达到更少的不良反应和更高的安全性。由于纳入研究样本量小,方法学质量问题较多,无法得出具有临床指导价值的结论。大样本,
更新日期:2021-08-01
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